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This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil | Active Comparator | Active Ingredient |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Placebo-control |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF | 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the total score of IIEF at the end of the treatment compared to baseline. | 8 week | |
| Changes in score of Question 3 (SEP2) and Question 4 (SEP3) of IIEF questionnaire at the end of the treatment period as compared to baseline. | 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara | 06100 | Turkey (Türkiye) | ||||
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| Drug |
Placebo |
|
| Overall assessment of efficacy (GAQ) to the study medication at the end of the study. | 8 week |
| Ankara |
| Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Mersin | 33343 | Turkey (Türkiye) |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |